PROMETAL HN86— 510(k) K052463

Substantially Equivalent

Prometal Technologies

FDA 510(k) clearance K052463 for PROMETAL HN86, Substantially Equivalent on 2005-10-14. Applicant: Prometal Technologies. Device class: 2.

Clearance details

Applicant: Prometal Technologies
Product code: Code EJT
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 2005-09-08
Decision date: 2005-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Silver Creek, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.